Trial reportIntensive care medicine2018
Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study).
Trial report in Intensive care medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01420744 (A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group, Adaptive Group-sequential Phase II Study, to Determine the Efficacy and Safety of BT086 as an Adjunctive Treatment in Severe Community Acquired Pneumonia), which is not on this map. Cited by 79 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group, Adaptive Group-sequential Phase II Study, to Determine the Efficacy and Safety of BT086 as an Adjunctive Treatment in Severe Community Acquired Pneumonia (sCAP)
Who cites it
79 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- IgM-Enriched Immunoglobulin As Adjunctive Therapy in Adult Sepsis and Septic Shock: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Critical care explorations · 2026Pooled it
- Systematic review and meta-analysis of humoral immunity proteins and mortality in sepsis.Critical care (London, England) · 2025Pooled it
- Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review.Critical care (London, England) · 2023Pooled it
- [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020Guideline
- High-dose intravenous immunoglobulin versus albumin 4% in paediatric toxic shock syndrome: a randomised controlled feasibility study.Archives of disease in childhood · 2024Trial
- Efficacy and safety of trimodulin in patients with severe COVID-19: results from a randomised, placebo-controlled, double-blind, multicentre, phase II trial (ESsCOVID).European journal of medical research · 2024Trial
- The immunomodulating activity of trimodulin (polyvalent IgM, IgA, IgG solution): a post hoc analysis of the phase II CIGMA trial.Critical care (London, England) · 2023Trial
- Trial
- Pneumolysin induces platelet destruction, not platelet activation, which can be prevented by immunoglobulin preparations in vitro.Blood advances · 2020Trial
- XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial.Critical care medicine · 2019Trial
- Phenotype-based appropriateness of IGM-enriched polyclonal immunoglobulin use in critical illness: report of an expert consensus.Journal of anesthesia, analgesia and critical care · 2026Review
- Electroacupuncture as Adjunctive Therapy for Organ Dysfunction Among Chinese ICU Patients with Sepsis: Study Protocol for a Randomized Clinical Trial.Current medical science · 2026Article
- Clinical practice in using corticosteroids and adjunctive sepsis therapies at the bedside among European ICUs: an ESICM-endorsed survey.Intensive care medicine experimental · 2026Article
- Hemodynamic Effect of IgM-Enriched Immunoglobulin in the Early Stage ofJournal of clinical medicine · 2026Article
- Modes of (Inter)Actions of Polyvalent Immunoglobulins: Nonclinical and Clinical Research in Severe Bacterial Infections.Biomedicines · 2026Review
- Trimodulin supports antibacterial defence and restricts inflammation in preclinical pneumonia models.The European respiratory journal · 2026Article
- Review
- Severe community-acquired pneumonia: an integral approach.Journal of intensive care · 2026Review
- Severe Necrotizing Community-Acquired Pneumonia and Bilateral Empyema in an Immunocompetent Patient due toCase reports in pulmonology · 2026Article
- Polymeric immunoglobulin receptor (pIgR) in cancer progression: a critical role and potential therapeutic target.Apoptosis : an international journal on programmed cell death · 2025Review
19 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
43 authors.
Funding
Abstract
purposeThe CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing ~ 23% immunoglobulin (Ig) M, ~ 21% IgA, and ~ 56% IgG as add-on therapy for patients with severe community-acquired pneumonia (sCAP).
methodsIn this double-blind, phase II study (NCT01420744), 160 patients with sCAP requiring invasive mechanical ventilation were randomized (1:1) to trimodulin (42 mg IgM/kg/day) or placebo for five consecutive days. Primary endpoint was ventilator-free days (VFDs). Secondary endpoints included 28-day all-cause and pneumonia-related mortality. Safety and tolerability were monitored. Exploratory post hoc analyses were performed in subsets stratified by baseline C-reactive protein (CRP; ≥ 70 mg/L) and/or IgM (≤ 0.8 g/L).
resultsOverall, there was no statistically significant difference in VFDs between trimodulin (mean 11.0, median 11 [n = 81]) and placebo (mean 9.6; median 8 [n = 79]; p = 0.173). Twenty-eight-day all-cause mortality was 22.2% vs. 27.8%, respectively (p = 0.465). Time to discharge from intensive care unit and mean duration of hospitalization were comparable between groups. Adverse-event incidences were comparable. Post hoc subset analyses, which included the majority of patients (58-78%), showed significant reductions in all-cause mortality (trimodulin vs. placebo) in patients with high CRP, low IgM, and high CRP/low IgM at baseline.
conclusionsNo significant differences were found in VFDs and mortality between trimodulin and placebo groups. Post hoc analyses supported improved outcome regarding mortality with trimodulin in subsets of patients with elevated CRP, reduced IgM, or both. These findings warrant further investigation.
trial registrationNCT01420744.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.